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DPP-4 Inhibitor Alogliptin Rejected by FDA

Updated: 8/14/21 11:00 amPublished: 5/31/12

In April, the FDA denied approval of the DPP-4 inhibitor alogliptin in the US. Takeda (the drug’s manufacturer) has not yet revealed the reasons behind the FDA’s decision, although the company believes it can address the agency’s concerns with already available data and results from ongoing studies. Takeda has indicated that it plans to reapply for approval shortly, with an expectation that the drug could be approved by early 2013. As a reminder, alogliptin has been available in Japan since 2010 under the brand name Nesina. DPP-4 inhibitors are type 2 diabetes therapies that help the body secrete insulin only when blood glucose levels are high – so there is no hypoglycemia associated with the drugs, and there is also no weight gain, unlike with a number of current diabetes therapies. There are three currently approved DPP-4 inhibitors in the US, including Januvia (sitagliptin), Onglyza (saxagliptin), and Tradjenta (linagliptin).

Based on the studies we’ve seen, alogliptin appears to be quite similar to the already approved DPP-4 inhibitors in many respects. But what could distinguish alogliptin is that it may also become available in combination, in a single pill, with the type 2 diabetes therapy Actos (pioglitazone). Actos is a TZD (thiazolidinedione) and works to improve blood glucose control by increasing the body’s sensitivity to insulin. Therefore, by targeting both insulin secretion (with a DPP-4 inhibitor) and insulin resistance (with a TZD), a combination alogliptin/Actos pill could form a very useful therapy for many people with type 2 diabetes. We note that some studies have associated use of Actos for more than one year with bladder cancer. In response, the FDA recently updated the medication’s label and will be looking for further clarity as more extensive trial data becomes available. For more information, please see new now next in diaTribe #34. Over the coming months, we’ll be keeping our ears to the ground for any more information surrounding alogliptin’s rejection and Takeda’s plans to resubmit the drug for approval in the US. Meanwhile, alogliptin is under review for approval in Europe, and a decision is expected in 2013. –BK

 

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